ISO Contamination Control Standards
The ISO standards on cleanrooms and associated controlled environment should be used by suppliers and customers to establish and to demonstrate contamination control with respect to contaminants of interest (particles, macro-particles, nano-particles, chemicals and micro-organisms. There should always be requirements for the air cleanliness with respect to airborne particles ≥ 0.1 µm up to ≥ 5 µm. This air cleanliness is the base for classification of a cleanroom as described in ISO 14644-1. Other airborne and surface contaminants may be added for monitoring purposes. These contaminants and the associated standards are shown in the table below. A risk assessment should be performed to determine the required cleanliness levels. Standards for design, construction and start-up of cleanrooms and separate devices may be used to establish control and the standard on measurement methods and measurement methods in the contaminant standards can be used to verify the established control. During operation, the operation and cleaning standard may be applied. To demonstrate control the contaminant standards and measurement methods should be used. In the table below an overview is given.
| Contaminants | Particles | Macro-particles | Nano-particles | Chemicals | Micro-organisms |
|---|---|---|---|---|---|
| Requirements | 14644-1,2,9 | 14644-1,9,17 | 14644-12 | 14644-8,10 | 14698-1,2 EN17141 |
| Establish Control | + 14644-3,4,7,14 |
Requirements + 14644-4,14 |
+ 14644-4,7 |
+ 14644-4,7,15 |
+ 14644-4,7 |
| Demonstrate Control | + 14644-3,5,13 |
+ 14644-3,5,13 |
+ 14644-5 |
+ 14644-5,13 |
+ 14644-5 |
ISO 14644 - Cleanrooms and associated controlled environments
| ISO Part | Name | Year |
| 14 644-1 | Classification of air cleanliness by particle concentration | 2015 |
| 14 644-2 | Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration | 2015 |
| 14 644-3 | Test methods | 2019 |
| 14 644-4 | Design, construction and start-up | 2022 |
| 14 644-5 | Cleanroom operations (in revision CD 2023) | 2004 |
| 14 644-7 | Separative devices (clean air hoods, glove boxes, isolators and minienvironments) | 2004 |
| 14 644-8 | Assessment of air cleanliness by chemical concentration (ACC) | 2022 |
| 14 644-9 | Assessment of surface cleanliness for particle concentration | 2022 |
| 14 644-10 | Assessment of surface cleanliness for chemical contamination | 2022 |
| 14 644-12 | Specifications for monitoring air cleanliness by nanoscale particle concentration | 2018 |
| 14 644-13 | Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical concentrations | 2017 |
| 14 644-14 | Assessment of suitability for use of equipment by airborne particle concentration | 2016 |
| 14 644-15 | Assessment of suitability for use of equipment and material by airborne chemical and surface chemical concentration | 2017 |
| 14 644-16 | Energy efficiency in cleanrooms and separative devices | 2019 |
| 14 644-17 | Particle Deposition Rate Applications | 2021 |
| 14 644-18 | Assessment of suitability of consumables | 2023 |
ISO 14698 - Cleanrooms and associated controlled environments -Biocontamination control
| ISO Part | Name | Year |
| 14 698-1 | General Principles | 2004 |
| 14 698-2 | Evaluation & Interpretation of Biocontamination Data | 2004 |
| EN17141 Replaced ISO14698 in Europe |
Biocontamination – Microbial Control | 2020 |
| ISO 14644-20 | Cleanrooms and associated controlled environments — Part 20: Microorganisms |
Under Development |